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# Ritter Pharma Plans Phase 3 Study on Lactose Intolerance Drug
- URL: https://www.fdaweb.com/ritter-pharma-plans-phase-3-study-on-lactose-intolerance-drug/
- Published: 2017-08-18T12:00:00.000Z
- Updated: 2026-09-14T22:42:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139415

FDA has provided guidance to Ritter Pharmaceuticals for it to begin a Phase 3 trial for RP-G28 for treating lactose intolerance. In a recent End-of-Phase 2 meeting, the company says it “incorporated guidance from the FDA on key elements of its Phase 3 program and received clear guidance and expectations on necessary components, including clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements needed to support a successful NDA submission... Having guidance and agreement on key clinical items such as screening methods to ensure an appropriate patient population, validated measures to capture appropriate clinical outcomes and well-defined endpoints for assessment, the company is well-positioned to enter Phase 3 trials.”

Ritter says the 3 clinical program will include two confirmatory clinical trials of similar trial design and size as the its Phase 2b/3 clinical trial, and will include additional components to allow for claims for durability of effect. It anticipates initiating the Phase 3 program during the first half of 2018.

RP-G28 is a non-digestible oligosaccharide of “ultra-high purity,” the company says, developed to modulate the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal tract to metabolize lactose to improve lactose tolerance.